Recall Z-2266-2014— Vascutek, Ltd.

Name: FDA recall Z-2266-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-15

Class II · Terminated

Class II FDA medical device recall by Vascutek, Ltd., initiated 2014-07-15, terminated 2015-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company. Reason: The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively)..

Recalling firm: Vascutek, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2014-07-15
Terminated: 2015-03-19
Firm location: Inchinnan, United Kingdom

Product description

Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

Reason for recall

The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).

Data sourced from openFDA. This site is unofficial and independent of the FDA.